Method for treating bone fracture

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Nitrogen containing other than solely as a nitrogen in an...

Reexamination Certificate

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C514S671000

Reexamination Certificate

active

06727288

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention relates to a method for treating or preventing bone fracture, and in particular relates to a method for treating or preventing bone fracture by administering an effective amount of calcium L-threonate to a subject in need of such prevention or treatment.
Bone fracture is a disruption of structure continuity of a bone, and it is a common surgical disease. Bone fracture can be classified into traumatic fracture and pathological fracture. Traumatic fracture is caused by external force, and pathological fracture is due to the pathological change of bone itself, such as senile osteoporosis, along with a certain degree of external force on the bone.
Traditionally, bone fracture healing is classified into four phases: 1) inflammation, 2) soft callus, 3) hard callus and 4) remodeling. The inflammation phase is an immediate response following bone fracture. At that time, a hematoma occurs at the fracture site and the adjacent tissues, and an acute inflammation response occurs immediately, which is manifested by blood vessels dilating, and the effusing of plasma and leukocytes. The soft callus phase is a period from the disappearance of swelling and pain to the connection of fibers or cartilage tissue at the fracture site, during which the hematoma is organized, osteoclasts remove residual necrotic bone, and intramembranous ossification begins to form. Its characteristic is that blood vessels increase greatly, capillary vessels grow into callus, and cells are very abundant. The hard callus phase is a period from the adhesion of soft callus at the fracture site to the formation of new bone. This phase corresponds to the period of bone fracture healing in clinic or X-ray representation. It generally takes three to four months, during which callus changes to fibrous bone from fibrocartilage tissue, and membranous bone forms between the fracture sites. Their remolding phase is a process in which the fracture sites are connected by newly born bones and gradually adapt to new functions.
Bone fracture healing is a very unique process of tissue repair program. It is different from the repair of other tissues, since the result of other tissue repair is cicatrization, whereas bone repair is not by cicatrization but by regeneration of bone. Therefore the proliferation of osteoblasts plays a crucial role in bone fracture healing.
In addition, Lane classified bone fracture healing from the view point of biochemistry: 1) mesenchyma phase, when collagen I, II and III is synthesized; 2) cartilaginous phase, when collagen II is predominant; 3) cartilage and osteoid phase, when collagen I and II is predominant; 4) osteogenesis phase, when collagen I is predominant. Therefore, the synthesis of collagen plays a very important role in bone fracture healing.
Now it is generally believed that conventional calcium formulations have no significant effects on promoting bone fracture healing. In addition, other drugs that can significantly promote bone fracture healing are not found yet. The major treatment of bone fracture is still the combination of the following three traditional means: 1) restoration of bone fracture; 2) fixation; 3) functional exercise.
Therefore, an object of the present invention is to provide a method for preventing or treating bone fracture, which comprises administering an effective amount of calcium L-threonate to a subject suffering from bone fracture.
It is another object of the present invention to provide a pharmaceutical composition for preventing or treating bone fracture, comprising an effective amount of calcium L-threonate.
It is a further object of the present invention to provide the use of calcium L-threonate in the preparation of a pharmaceutical composition for treating or preventing bone fracture.
It is still another object of the present invention to provide calcium L-threonate usable for preventing or treating bone fracture.
It is a further object of the present invention to provide use of calcium L-threonate for preventing or treating bone fracture.
In view of the above factors that facilitate bone fracture healing, the present inventors studied the stimulation effects of calcium L-threonate on proliferation, differentiation of osteoblasts and bone formation, as well as the effects of calcium L-threonate on promoting synthesis of collagen I. The result is astonishing that calcium L-threonate can not only facilitate the proliferation, differentiation and mineralization of osteoblasts, but also can enhance mRNA expression of collagen I in osteoblasts cultured in vitro. By this means, it can promote bone fracture healing and treat bone fracture, whereby the inventor completed the present invention.
Meanwhile, through the above-mentioned effects, calcium L-threonate can increase bone density and mechanical properties, so as to prevent bone fracture, especially pathological fracture, such as the fracture caused by senile osteoporosis.
BRIEF SUMMARY OF THE INVENTION
The present invention relates to a method for treating bone fracture, which comprises administering an effective amount of calcium L-threonate to a subject suffering from bone fracture. As used herein, the term “bone fracture” includes but is not limited to traumatic fracture and pathological fracture.
The present invention also includes a method for preventing bone fracture, preferably traumatic fracture and pathological fracture, more preferably traumatic fracture, which comprises administering an effective amount of calcium L-threonate to a subject suffering from bone fracture.
The present invention also relates to a pharmaceutical composition for preventing or treating bone fracture, comprising an effective amount of calcium L-threonate.
The present invention further includes the use of calcium L-threonate in the preparation of a pharmaceutical composition for treating or preventing bone fracture.
The present invention also relates to calcium L-threonate usable for preventing or treating bone fracture.
The present invention also includes use of calcium L-threonate for preventing or treating bone fracture.


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